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Saturday, March 12, 2011

Shots to prevent preterm labor rise

Shots to prevent preterm labor rise

The dramatic cost increase of a drug that prevents preterm labor in high-risk expectant mothers has some doctors crying foul.

"Only in America would this criminal act be legal," said Dr. Ronald Thomas, director of maternal-fetal medicine with West Penn Allegheny Health System. "It's good old American greed."

Next week, the drug Makena will shoot up from $10 to $20 per injection to $1,500 a dose. The drug, a form of progesterone given as a weekly shot, has been made cheaply for years — mixed in special pharmacies that custom-compound treatments that are not federally approved.

KV Pharmaceutical of suburban St. Louis recently won government approval to sell the drug exclusively. The company sent cease-and-desist letters to compounding pharmacies.

"The company did not invent the medication or develop it," said Dr. Hyagriv Simhan, medical director of obstetrical services at Magee-Womens Hospital of UPMC. "They're not recouping the cost of large trials — they didn't do those trials."

The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical CEO Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone."Makena can help offset some of those costs," Divis said. "These moms deserve the opportunity to have the benefits of an FDA-approved Makena."

Doctors are concerned that the price increase could deter low-income women from receiving Makena injections and be a financial burden for insurance companies and government programs.

Makena is a synthetic form of progesterone that entered the market more than 50 years ago. In the 1990s, a decline in use led the early incarnation of Makena to be withdrawn from the market.

The drug got a new life in 2003, with publication of a study that reported it helps prevent early births in women with a history of spontaneous preterm deliveries. By some estimates, about 130,000 women a year could benefit from Makena.The drug is administered weekly during weeks 16 to 36 of pregnancy. The cost for the term of treatment is about $400. With the price increase, the cost could run $30,000.

"Costs like this are unsustainable to the health-care system," said Highmark spokesman Aaron Billger, noting that Highmark doesn't pay for the compounded version of the drug.

"With the recent FDA approval, we are assessing the clinical trials, medical evidence and benefits to the patient to make a determination," Billger said.

While the drug is under review, Highmark will evaluate patients on a case-by-case basis to determine whether the insurer will pay for it, he said.

Dr. Douglas MacKay, an obstetrics/gynecology physician with St. Clair Hospital, said he expects that KV Pharmaceutical will find a way to make the cost more bearable for insurance companies.

"There is no way a $30,000 medication can be afforded in the current health-care system," he said.The FDA is not involved in setting the price for drugs that it approves.

A KV subsidiary, Ther-Rx Corp., will market the drug. Ther-RX announced a patient-assistance program to help uninsured and low-income women receive Makena.

Some of the burden will fall on health insurance companies, which will have to raise premiums or other costs to other customers. And some will fall on cash-strapped state Medicaid programs.

Michael Race, state Department of Public Welfare spokesman, said the agency doesn't know whether Makena would be covered through the Medicaid program.

"We could place utilization controls on the drug — like requiring prior authorization to ensure medical necessity and appropriate use — but it wouldn't lower the manufacturer-set cost," he said.